Pharmacogenetics of Bupropion Metabolism
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Bupropion is widely used in the treatment of depression and for smoking cessation. It's most abundant metabolite, hydroxybupropion, may be responsible for most of the therapeutic effect of bupropion under conditions of long term dosing. Because the primary enzyme involved in metabolism of bupropion to hydroxybupropion is the liver enzyme CYP2B6, we propose to study the effect of different CYP2B6 genotypes on the metabolism of bupropion. These data will guide the use of genotypes as a surrogate for measuring drug blood levels in studying genetic determinants of outcomes for bupropion treatment.
A minimum of Forty-four subjects with 4 different CYP2B6 genotypes will participate in a 7-day study in which they take bupropion as outpatients for 6 days (to achieve steady state drug levels) and then come to the San Francisco General Hospital (SFGH) Clinical Research Center for a 1-day admission during which multiple blood and urine samples will be collected for pharmacokinetic analysis.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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California
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San Francisco, California, États-Unis, 94110
- San Francisco General Hospital-Clinical Research Ward
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Age: 18 - 65 years
- Gender: Either
- Ethnic/Racial Group: Any
- Smoking Status: Both smokers and non-smokers are eligible
- CYP2B6 genotype: CYP2B6 *1/*1 (11 subjects); *4, *5 and *6 alleles (11 each) [44 subjects total] Up to 15 additional subjects may be studied with genotypes that do not fall into one of the primary groups.
Exclusion Criteria:
- Medical: Exclude most any chronic illness requiring regular medication.
- Cardiac: History of angina or other serious heart disease; ECG abnormalities on screening.
- Hypertension: screening visit BP of 150/95 or more after 5 min rest
- Respiratory: Asthma - acceptable if in remission, otherwise exclude.
- Systemic: "Morbidly Obese" Exclude if BMI > 35
- Diabetes: By history
- Chronic Active Hepatitis: By history; elevated Liver Function Tests
- Cancers: By history
- Pregnancy/breastfeeding: By history; positive urine pregnancy test
- Seizures: individuals with a history of seizures will be excluded (risk factor for bupropion-induced seizures)
- Eating Disorders: individuals with a history of eating disorders will be excluded (risk factor for bupropion-induced seizures)
- Head Trauma: individuals with a history of head trauma will be excluded (risk factor for bupropion-induced seizures)
- Other tobacco users (pipe, cigar, chewing tobacco, snuff users
- Medications/Supplements: General Exclusion = "any regular oral and/or prescription drug use"; current use of oral contraceptives or other female hormones.
- Drug/alcohol use: no alcohol abuse by history, no regular recreational drug use, any intravenous drug abuse, recent history of Treatment program
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Area under the plasma concentration versus time curve (AUC) for bupropion
Délai: 0, 4, 8, 12, 16,24 hours from steady state
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Subjects took bupropion daily for 7 days as outpatients prior to the study day to allow them to reach steady state concentrations of bupropion and its metabolites.
The time frame shown is measured from 08:00 on the morning of inpatient admission.
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0, 4, 8, 12, 16,24 hours from steady state
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- H133-31868
- U01DA020830 (Subvention/contrat des NIH des États-Unis)
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